A Prozac class action lawsuit was filed before the Superior Court in Montreal on January 14. Giant drug maker Eli Lilly is alleged to have withheld vital information on the safety of Prozac, its flagship drug for years. Yesterday, the Indianapolis based drug maker completely vindicated the British Medical Journal, which it had charged earlier this week with misleading its readers, when it posted a document on its website called Annotations. Eli Lilly had been invited on numerous occasions to answer whether a document called Summary of a preliminary analysis of clusters of adverse events based on pooling data from multiplestudies was authentic and whether it had been released to health authorities around the world. (Related article: Is Prozac recall next?)
Eli Lilly confirmed the authenticity of the document and implicitly admitted that it had never been released to health authorities, including the FDA, or anyone else. The document consisted of data stemming from numerous studies conducted by Eli Lilly and that showed that Prozac caused activation in 38% of its users compared with 19% with placebo and 4% for Tricyclic, a then well known drug in the treatment of depression.
When Eli Lilly representatives attended the FDA hearings on the safety of Prozac in 1991, they had known the existence of the study for years but failedto disclose it to the FDA, in the word of the lead plaintiff's attorney, "lest it should warrant a much stringent warning on the label of the drug withregard to its safety, thereby seriously hampering Eli Lilly's efforts to market its new drug as effective and safe." In the words of Serge Petit of thelaw firm Petit Desjardins based in Montreal, Canada, that represents the lead plaintiff "such a likelihood was looming large since Eli Lilly knew that ifdoctors had been made aware that Prozac, back then being introduced as the new kid on the block, caused activation in 38% of its users compared with 19% ofpatients taking a placebo and 4% of those taking a drug then well known to doctors, Tricyclic, they would certainly have hesitated before prescribingProzac. It was nearly a ten folds increase in activation compared with the other drug they could prescribe."
The lead plaintiff contends that the reason why Eli Lilly failed to disclose the document to Health authorities was that it would have placed another study, that consisted of a pooling of what is called spontaneous reports and showed alarming increases in suicide attempts and other violent acts in patient using Prozac as compared with four other drugs, in a totally new perspective and prevent it from being dismissed by FDA and Eli Lilly as inconclusive. To Serge Petit "had the study on activation and the one on spontaneous reports been put side by side before the FDA, Eli Lilly would have faced an uphill battle as to the safety of its drug".
The class action contends that Eli Lilly misled health authorities around the world and therefore the millions of users of its drug Prozac around theworld as to the safety of its drug by failing to disclose the said document. To Serge Petit, "the passage of time cannot condone Eli Lilly's behavior andit must be held accountable for circumventing the safeguards that have been put in place to protect the public health." The lead plaintiff is seeking $10,000 in punitive damages and $5 000 for herself and each member of the group from Eli Lilly for misrepresenting the safety of its drug.